Manufacturing Technician IV, Lead

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

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Job Summary

The Lead Technician is a direct labor position on the Manufacturing floor, which supports Filling operations. The position leads the execution of batch activities on the manufacturing floor, requires operating equipment in various controlled/non-classified and classified areas, product sampling, line clearances, data collection and completing batch record entries. In addition, the Lead Technician will perform setup of equipment, execute training for other Technicians, direct product sampling activities and perform batch reconciliation and accountabilities per cGMPs.

The Lead Technician will also serve as a resource for the implementation of continuous improvement projects.

Primary Responsibilities

• Lead and monitor process execution activities to ensure successful operations on the production floor. Typical duties include leading daily Tier 0 meetings, assigning daily tasks to production technicians, monitoring material and supply levels, and coordinating production tasks such as batch execution and turnover activities.

• Act as a first-line resource for the team. Provide support to production technicians and mechanical technicians. Resolve production-related issues such as batch set-up, execution, technical intervention, documentation, equipment operations, SOPs, and safety and quality inspection procedures.

• Perform clean in place and steam in place of process lines per SOPs.

• Perform, set up, and create single use connections including single use bags.

• Perform and execute filter integrity testing as needed per SOP.

• Perform parts washing of parts as necessary.

• Perform dispensing operations as necessary.

• Perform inventory control and reconciliation activities, which will require the use of SAP.

• Perform technician tasks as required including start-up, equipment operation, batch execution, material handling, cleaning, housekeeping and line clearance activities

• Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.

• Manage batch records and GMP documentation on the production floor. Review documentation for completeness and accuracy per GxP standards within established timelines. Assist and train others to complete documentation as required. This will include mathematical computation where needed.

• Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines.

• Knowledge of light material handling equipment.

• Act as a certified OJT trainer on the team on assigned equipment and process tasks. Train and conduct evaluations on other team members for training qualifications.

• Working knowledge of automated and semi-automated equipment.

• Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls.

• Support lean activities such as performing 5S in the work area, participating in problem-solving, and process improvement analysis. Lead Level 0 problem-solving on process related issues and generate One Point Lesson communications as needed.

• Responsible for assembling, disassembling, and sanitizing various equipment.

• Familiarity with chemical handling and spill control procedures in connection with hazardous waste pick-up duties.

• Be flexible in training and support other formulation functions and work areas as needed.

• Assist technical staff as required with preventive maintenance procedures

• Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed.

Minimum Qualifications

• Experience in a pharmaceutical production environment

• Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language

• Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations

Preferred Qualifications

• High school graduate, vocational school graduate or equivalent

• Working knowledge of Microsoft applications, SAP and Veeva Vault

• Experience working in a LEAN manufacturing environment

• Knowledge of cGMPs and FDA policies/procedures

This position may also include the following conditions:

• Acquire and maintain all required certifications and qualifications for the assigned work area

• Maintain Aseptic Processing and Gowning certifications as required

• Strong verbal and written communication skills

• Proven ability to work effectively in a team environment

• Strong mechanical and technical knowledge and aptitude

• Ability to interpret technical…